510(k) Report

Devices descending from K181520

6 later devices reach Sirona Dental CAD/CAM System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+1K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+1K191152MIS Ti-base AbutmentDentsply Sirona20201—
+2K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+2K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+2K211225MIS Ti-base abutmentDentsply Sirona20210—